TECNIS ODYSSEY IOL DRN00V (REF DRN00V0130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474810624), received between Oct 18, 2024 and Apr 27, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. THE LENS WAS SUBSEQUENTLY EXPLANTED FOR UNSPECIFIED REASON DURING A SECONDARY SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH IMPLANTATION OF A REPLACEMENT LENS OF A DIFFERENT MODEL (DIB00, +13.0 D). THE PATIENT¿S OUTCOME IS UNKNOWN. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 25010126 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S OPERATIVE EYE DUE TO BLURRY VISION NOT ABLE TO CORRECT WITH REFRACTION. VISION PREOPERATIVE 20/40 -1 AND POST OPERATIVE 20/150 +1. THE LENS WAS REPLACED WITH A DIB00 MODEL IOL, WHICH HAS A POWER OF 14.0. THE PROCEDURE WAS CARRIED OUT WITHOUT COMPLICATIONS, AND IT DID NOT REQUIRE INCISION ENLARGEMENT, SUTURES, OR A VITRECTOMY. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE ACCOUNT SUGGESTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE PATIENT HAD NO PRE-EXISTING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT, ASIDE FROM DRY EYE SYNDROME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 23045625 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS HAD A TEAR ON THE POSTERIOR HAPTIC. THE LENS MADE CONTACT WITH THE PATIENT, AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538708 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). POST-OPERATIVELY, THE PATIENT'S ASTIGMATISM WAS TOO SIGNIFICANT, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT 225 13.0 IOL. PATIENT SYMPTOMS PERSISTED FOR SIX (06) WEEKS. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE; HOWEVER POST-OPERATIVE DROPS WERE PRESCRIBED. PATIENT'S VISION PRE-OPERATIVE WAS REPORTED AS 20/60 AND POST-OPERATIVE WAS 20/20. PATIENT STATUS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS NOT SAVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22517114 ↗
• MalfunctionOct 18, 2024Difficult to Fold, Unfold or Collapse; Ejection Problem; Difficult to Fold, Unfold or Collapse; Ejection Problem

  IT WAS REPORTED THAT WHEN THE DOCTOR INSERTED THE PRELOADED INTRAOCULAR LENS (IOL) THE EXTENDED TRAILING HAPTIC BECAME TRAPPED BETWEEN THE CARTRIDGE AND THE ROD, MAKING IT DIFFICULT FOR THE DOCTOR TO REMOVE IT FROM THE CARTRIDGE. NO PATIENT INJURY WAS REPORTED. FURTHER INFORMATION RECEIVED CONFIRMED THAT THE TRAILING HAPTIC WAS CAUGHT IN THE WOUND AND ADDITIONAL SURGERY WAS PERFORMED TO RELEASE THE TRAILING HAPTIC WITH FORCEPS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483313 ↗